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In the Biopharma industry, navigating M&A and licensing deals is challenging due to strict antitrust laws and shifting regulations. When these pressures create significant risks, nullifying or restructuring existing agreements can be the most rational and strategic response
In 2024, the termination of the $4.45B deal between Adaptimmune and Genentech became a major talking…
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The EC has approved Opdivo + Yervoy as 1L therapy to treat inoperable or advanced HCC adult pts in 30 EEA states; sBLA under the US FDA’s priority review (PDUFA: Apr 21, 2025)
Approval was based on P-III (CheckMate-9DW) trial assessing Opdivo (1mg/kg, Q3W) + Yervoy (3mg/kg, Q3W), followed by Opdivo alone (480mg,…
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The CHMP has granted positive opinion to Opdivo + CT (cisplatin & gemcitabine) as 1L treatment of metastatic or unresectable urothelial carcinoma adults (n=608). The decision is anticipated in Jun 2024
The opinion was based on a sub-study of the P-III (CheckMate–901), assessing Opdivo (360mg, Q3W, 6 cycles) + CT (cisplatin & gemcitabine) followed…
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The EMA approved 2 BLA and 6 New Chemical Entities in January 2024, leading to treatments for patients and advances in the healthcare industry
In January 2024, the major highlighted drugs were Padcev to treat Bladder Cancer and Eylea for the treatment of Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)
PharmaShots has…
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Driven by mutual growth and expansion, strategic collaborations are embedded deeply in the modus operandi of life sciences deals. In 2023, the volume of life science deals was comparatively high vs. 2022
The collaboration deal between Daiichi Sankyo and Merck & Co. for $22B ranks first in our list followed by the development and…
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The CHMP positive opinion was based on the results from the P-III (KarMMa-3) clinical trial evaluating Abecma vs standard regimens in patients with r/r multiple myeloma following 2-4 prior lines of therapy. The 1EP of the study was PFS & 2EPs were ORR & OS
Following a median follow-up of 30.9mos., the study showed…
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The EMA has validated MAA of Augtyro for treating adults and pediatric patients (12yrs. & older) with ROS1+ and NTRK+ locally advanced or metastatic solid tumors incl. NSCLC
The application was based on two P-I/II (TRIDENT-1 & CARE) trials assessing the safety, tolerability, PK and anti-tumor activity in adults with ROS1+ NSCLC or NTRK+…
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Gina gave her views on the acceptance of the sBLA by the US FDA and the validation of the Type II Variation Marketing Authorization Application by the EMA for Opdivo as monotherapy for the treatment of patients with completely resected stage IIB or IIC melanoma
She also spoke on the epidemiology of melanoma and…
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The first quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Meanwhile, Selecta and Sobi reported P-III trial (DISSOLVE I & II) results of SEL-212 for chronic refractory gout
Starting with the latest acquisitions, Pfizer acquired Seagen for ~$43B. The first quarter of the year also showcases…
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The technological advancement, shared cost, and the pursuit of combined extensive research are amongst the few pragmatic and mutual benefits that come with collaborations. Moreover, the risks involved in drug development plans get minimalized by opening the doors to new opportunities and commercialization
When it comes to life science collaborations, companies seek beyond the…

